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Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression

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Trial Profile

Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Mar 2026

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At a glance

  • Drugs Ketamine (Primary) ; Cycloserine/lurasidone
  • Indications Bipolar depression; Suicidal ideation
  • Focus Registrational; Therapeutic Use
  • Acronyms SevereBD
  • Sponsors NeuroRX; NRx Pharmaceuticals

Most Recent Events

  • 16 Mar 2026 According to a NRx Pharmaceuticals media release, company announced that it has received confirmatory minutes from an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. NRx agreed with FDA to submit existing patient-level data for review.
  • 17 Feb 2026 According to a NRx Pharmaceuticals media release, the Companies will work collaboratively with the FDA in the coming weeks to finalize the statistical analysis protocol for the full 65,000 person Real World Evidence dataset under FDAs newly published guidance.
  • 17 Feb 2026 According to a NRx Pharmaceuticals media release,announced that it has completed an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration.Based on oral guidance received at the meeting, NRx believes it has a path to filing an application for New Drug Approval of NRX-100.NRx will additionally seek a broader indication to serve patients with treatment resistant depression in the context of suicidality, rather than only the subset of patients with suicidality.

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